Vivos Therapeutics (NASDAQ: VVOS) shares shot up by over 47 per cent Wednesday following the company’s announcement about receiving FDA approval for a youth sleep disorder treatment device.
Vivos claims that this is the first time the federal agency has approved a device specifically designed to treat obstructive sleep apnea (OSA) in young people aged 6-17. Over 10 million children in the United States are impacted by this condition, the company says.
“This landmark clearance opens up an exciting and vast new market and enables us to directly address the needs of millions of children who currently suffer from sleep-related breathing disorders such as OSA,” Chairman and chief executive, Kirk Huntsman, said in a statement.
This approval followed a multi-national study on the oral device at multiple sites yielding favourable results. It demonstrated a 62.7 per cent reduction in symptoms among trial participants who suffer from the condition.
Children with this disorder tend to have other health problems too. They have historically been an underserved demographic in sleep apnea therapy. These include asthma, nightmares, depression and a variety of other issues.
$VVOS – Vivos Therapeutics
🔹Receives Groundbreaking FDA 510(k) Clearance to Treat Moderate to Severe Pediatric Sleep Apnea and Snoring
🔹Super Low Float/ OS near 3.4M shares👆 23% PreM/ $3.43 pic.twitter.com/8ceI6NxG6N
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Sleep apnea treatment devices: a US$7.5 billion dollar industry
Researchers have predicted that the market for these devices will expand significantly in the coming years with a compound annual growth rate of about 7.5 per cent.
Vivos isn’t the only company to announce a significant achievement in the sleep apnea treatment sector this week.
Apple Inc (NASDAQ: AAPL) just received FDA approval for its watch’s sleep apnea detection feature. It works by analyzing irregular wrist movements to detect breathing disturbances and irregular breathing patterns.
Samsung Electronics Co Ltd (KRX: 005930) also obtained FDA approval for a feature that detects the condition in its wrist watch this February.
About eight out of 10 people who have the disorder remain undiagnosed.
rowan@mugglehead.com
